The comparative study of the efficacy and safety of Simeprevir sodium at investigational stage and after marketing authorizatio
Not Applicable
- Conditions
- Chronic hepatitis C
- Registration Number
- JPRN-UMIN000045086
- Lead Sponsor
- Shimane University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
Not provided
Exclusion Criteria
Subjects who declined use of their medical records for the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The proportion of subjects who meet the inclusion/exclusion criteria of clinical trials 2. The proportion of unavailable data on the case report form 3. Differences in baseline demographic characteristics 4. The proportion of subjects who achieved Sustained Virological Response (SVR) for 12 weeks and for 24 weeks 5. The proportion of subjects who completed 24-week treatment regimen 6. Frequency of ordering laboratory tests and other to monitor the subjects 7. Frequency and severity of adverse drug events 8. Exploratory sub-group analyses of efficacy and safety of the drug
- Secondary Outcome Measures
Name Time Method